Airway Microbiome of Cystic Fibrosis Patients

Cystic Fibrosis Clinical Trial

Official title:

Studying the Airway Microbiome of Cystic Fibrosis Patients and the Potential of Probiotics for the Airways

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06057558
• Other study ID #: B3002021000106
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: November 1, 2025

Study information

• Verified date: May 2024
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

With this study, the investigators first want to investigate the respiratory tract microbiome of cystic fibrosis patients. To achieve this, the investigators will collect longitudinal samples of saliva, throat and sputum and process these to determine the microbial composition and compare them over a timecourse of a year. Secondly, the investigators aim to study the influence of a topical microbiome therapy (throat spray) on the microbiome of the upper and lower respiratory tract in cystic fibrosis patients after administration for 6 weeks. Bacterial and cytokine profiles of salivary, throat and sputum samples will be monitored before, during and after intervention.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• Cystic fibrosis patients

• >6 years for intervention part of the study

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Biological:
• Probiotic throat spray
Throat spray containing Lacticaseibacillus casei AMBR2

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbial composition of saliva, throat and sputum samples using 16S rRNA sequencing		Change of microbial composition over one year (observational)
Primary	Transfer of L. casei AMBR2 to the oropharyngeal cavity and lungs after administration of the throat spray	qPCR	Transfer of probiotic over 6 weeks
Secondary	Changes in microbiome of the oropharyngeal region and lungs after administration of the throat spray	16S rRNA amplicon sequencing and shotgun sequencing	Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks
Secondary	Influence on general health	A clinical evaluation by a specialist will be performed at the different consultations to assess general and respiratory health. A certified questionnaire including questions about the quality of life will also be filled in during each consultation.	Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks
Secondary	Changes in cytokine levels (e.g. IL-10, IL-4, IL-5, IL-13) in saliva, oropharynx and sputum samples, and cytokine and antibody levels in blood samples	qPCR and/or ELISA	Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks